Clinical trials are required by the Food and Drug Administration (FDA) in the United States for approval of new therapies, medical devices, biologics, or other interventions to patients. They may be sponsored by a single physician, a small group of physicians, a commercial company, government, or an academic research body. Some trials may have multiple centers, and some may be international.
A source document, as used in clinical trials, is a document in which data collected for the trial is first recorded, or original data. The data contained in a source document is usually later entered in a case report form (CRF) as may be required by the clinical trial protocol. CRFs may be mailed to the sponsor at the conclusion of the clinical trial. Often during a clinical trial, a monitor may check the accuracy and completeness of the source documents, and other trial-related records. The monitor specifically may verify that the data required by the protocol are reported correctly on the CRF. An audit typically occurs at the completion of a clinical trial. An audit is a systematic and independent examination of trial-related activities and documents to determine, at least, whether the data were recorded, analyzed, and accurately reported. An audit includes a comparison of the data originally entered onto a source documents and the data in the CRF to ensure the accuracy of the data entered onto the CRF.
In some instances an auditor or monitor of the clinical trial will physically visit the clinical trial site to view the source documents and/or CRFs to ensure the accuracy of data entered into the CRF. This may be time intensive and costly, particularly when there are multiple centers involved in the clinical trial or when the clinical trial is conducted internationally.
21 C.F.R. Part 11 provides criteria under which the FDA will consider electronic records to be equivalent to paper records, and under which electronic signatures are equivalent to traditional handwritten signatures. Federal guidelines also provide that a certified copy of original information may be created by verifying, by signature, that the copy is an exact copy of the original.
One method of transferring clinical trial data is by facsimile. However, when a document is faxed, the sender does not have a way to certify that the fax received contains the same information that was contained in the original document. Original clinical trial documents may also be physically shipped to a central location and then archived.
Systems and methods are therefore needed that will allow monitors and auditors of a clinical trial to access or view clinical trial documents, including source documents and CRFs, at a centralized location, without the need to ship paper documents, while ensuring the clinical trial data is accurate and reliable. Additionally, systems and methods are required that will comply with the federal rules and guidelines regarding electronic signatures and certified copies of clinical trial documents.